The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Md300c318 Fingertip Pulse Oximeter.
| Device ID | K092620 |
| 510k Number | K092620 |
| Device Name: | MD300C318 FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NORTH BUILDING 3F, NO.9 SHUANGYUAN RD., BADACHU HITECH Shijingshan District, Beijing, CN 100041 |
| Contact | Yajing Li |
| Correspondent | Yajing Li BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NORTH BUILDING 3F, NO.9 SHUANGYUAN RD., BADACHU HITECH Shijingshan District, Beijing, CN 100041 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2009-12-04 |
| Summary: | summary |